Reproductive Health Survivorship Care Plan

NCT ID: NCT02667626

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-25
• Study Completion Date: 2019-01-24

Brief Summary

The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life.

Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.

Detailed Description

Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study.

YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.

Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions.

All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues.

Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.

Conditions

Breast Cancer; Hot Flashes; Sexual Dysfunction; Fertility; Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SCPR Intervention

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.

Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.

Group Type: EXPERIMENTAL

Reproductive Health Survivorship Care Plan (SCPR)

Intervention Type: OTHER

The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Control

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.

Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Web-based resource lists and text-based study adherence reminders

Interventions

Reproductive Health Survivorship Care Plan (SCPR)

The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Intervention Type: OTHER

Control

Web-based resource lists and text-based study adherence reminders

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Breast cancer (Stages 0-III) diagnosis
• Breast cancer diagnosis age ≤ 45 years
• ≤ 5 years since breast cancer diagnosis
• Current age 18 to 50 years
• Completed treatment with surgery, radiation and chemotherapy (if applicable)
• Able to read English
• Able to consent to the study
• Access to an Internet connection

Exclusion:

• Women who are pregnant at recruitment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Hui-Chun Irene Su

Professor of Obstetrics, Gynecology, and Reproductive Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H. Irene Su, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

140863

Identifier Type: -

Identifier Source: org_study_id